(582 days)
The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, alarming and storing of multiple physiological parameters These parameters include ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.
All parameters can be monitored on single adult, pediatric, and neonatal patients except:
- · BIS monitoring is intended for adult and pediatric patients only;
- · C.O. monitoring is restricted to adult patients only;
· Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population. - · When using COMEM SpO2, the monitor is intended to be used on adult patients only.
- · NIBP measurement continual mode is not applicable to neonates.
The monitors are to be used in general healthes by clinical physicians or appropriate medical staff under the direction of physicians.
The monitors are not intended for helicopter transport, hospital ambulance, or home use.
The monitors do not measure, display, or trend changes in the ST segment.
The monitors do not intend for use as apnea monitors.
The monitors are not intended for use in MRI or CT environments.
The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.
The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing multiple physiological parameters. These parameters include ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.
All parameters can be monitored on single adult, pediatric, and neonatal patients except:
BIS monitoring is intended for adult patients only; C.O. monitoring is restricted to adult patients only; Arrhythmia analysis is intended for use with adult patients only and is not intended and shall not be used on pediatric and neonatal population. When using COMEM SpO2, the monitor is intended to be used on adult patients only. NIBP measurement continual mode is not applicable to neonates. Both models are designed with:
Same system framework and components
Same hardware design principle
Same software platform
Same parameters measurement subsystems (including parameters modules and accessories)
The only difference between NC10 and NC12 is the display size.
The acceptance criteria and supporting study details for the Multi-Parameter Patient Monitor (NC10 and NC12) are provided below, based on the given FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present specific "acceptance criteria" for each physiological parameter in a tabular format with corresponding "reported device performance." Instead, it compares the subject device's specifications to those of the predicate device, stating that the subject device's performance aligns with or is a subset of the predicate's performance, and that the device meets relevant consensus standards. The "Comparison" column in the provided tables indicates "Same" for most parameters, implying that the subject device's performance is equivalent to the established performance of the predicate device. For the "Comen SpO2" feature, where there's a difference, the document states, "The SpO2 accuracy met ISO 80601-2-61 and was validated by the clinical study," indicating that its performance meets the standard.
Here's a condensed representation of the key performance specifications for the subject device (NC10 and NC12), which also serve as implied acceptance criteria given the "Same" comparison to the predicate:
| Parameter | Method / Range / Accuracy (NC10 & NC12) |
|---|---|
| ECG (Arrhythmia Analysis) | Asystole, ventricular fibrillation, R ON T, VT>2, Couplet, PVC, Bigeminy, Trigeminy, Brady, PNC, PNP, Missed Beats, Heart Pause, Irregular Heart Beat, VTAC, Tachy, PVCs Too High, Extreme Tachycardia, Extreme Bradycardia, Ventricular Rhythm. |
| Respiration | Method: Trans-thoracic impedance; Range: adult:0-120 rpm, pediatrics:0-150rpm, neonate:0-150rpm; Accuracy: 7 to 150rpm: ±2rpm or ±2%, whichever is greater. |
| SpO2 (Masimo) | Method: red and infrared light; Range: 1~100%; Accuracy: No motion: 70-100% ±2%(adult/pediatric), 70-100% ±3%(neonate); Motion: 70-100% ±3%. |
| SpO2 (Nellcor) | Method: red and infrared light; Range: 0~100%; Accuracy: 70-100% ±2%(adult/pediatric), 70-100% ±3%(neonate). |
| SpO2 (Comen) | Method: red and infrared light; Range: 0~100%; Accuracy: 70-100% ±3% (adult). (Note: Restricted to adult use compared to predicate) |
| Pulse Rate (from SpO2, IBP, NIBP) | Ranges: 20-350 bpm (variable by source); Accuracy: ±1bpm to ±5bpm or ±1% to ±3% (variable by source and conditions). |
| NIBP | Method: Oscillometry; Range: Adult: systolic:40-270 mmHg, diastolic:10-215 mmHg; Pediatrics: systolic:40-200 mmHg, diastolic:10-150 mmHg; Neonate: systolic:40-135 mmHg, diastolic:10-100 mmHg; Error: Max mean error: ±5 mmHg, Max standard deviation: 8 mmHg. |
| Temperature | Method: Thermal resistance; Range: 0-50°C; Accuracy: ±0.1°C. |
| CO2 (Masimo) | Method: Infrared absorption; Range: 0-190mmHg; AwRR:0-150rpm; Accuracy: 0-114mmHg: ±(2.25mmHg+reading×4%). |
| CO2 (Respironics) | Method: Infrared absorption; Range: 0-150mmHg; AwRR: 0, 2-150bpm; Accuracy: 0-40mmHg: ±2mmHg, other ranges higher % errors. |
| IBP | Method: Direct invasive measurement; Range: -50 to 300 mmHg; Accuracy: ±2% or ±1 mmHg, whichever is greater (excluding sensor error). |
| Cardiac Output | Method: Thermodilution; Range: 0.1 to 20 L/min; Accuracy: ±5% or ±0.1 L/min, whichever is greater. |
| Anesthetic Gas (AG) | Method: Infrared absorption; Ranges for various gases; Accuracy for CO2, N2O, Hal, Enf, Iso, Sev, Des, O2, awRR. |
| BIS | Range and Accuracy: SQI: 0-100%, 1%; EMG: 0 |
The document implies that the "reported device performance" for the subject device meets or is equivalent to these specified ranges and accuracies through bench testing and clinical studies, confirming compliance with relevant standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact numerical sample sizes for each clinical test. It mentions that clinical accuracy of NIBP, SpO2, and respiratory rate were validated for the intended patient population.
- For SpO2 accuracy, it states the validation was done "using the method outlined in ISO 80601-2-61:2017 and the FDA guidance Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, March 2013." These standards typically require a certain number of subjects (often healthy volunteers) with induced hypoxemia for desaturation studies to demonstrate accuracy across the specified range. However, the exact number is not provided in this summary.
- For NIBP accuracy, it states validation was "according to ISO 81060-2 which contains the requirements for clinical accuracy and the protocols for investigating the NIBP determination clinical accuracy." This standard also prescribes specific subject enrollment criteria and measurement methods.
- For Respiratory Rate (RR) accuracy, it was validated "by clinical testing to compare the measurement of the subject device and that of a clinician-scored capnography device, manually scored end-tidal CO2 (EtCO2) capnography." The sample size for this is not detailed.
- Data Provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state whether the studies were retrospective or prospective, though clinical validation studies for device clearance are typically prospective. It does say "All clinical accuracy validation studies were conducted in accordance with standard ISO 14155:2020," which governs clinical investigation of medical devices, generally implying prospective collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number or qualifications of experts used for establishing ground truth, as it is a multi-parameter patient monitor.
- For SpO2, the ground truth would typically be established by a CO-oximeter reading during a controlled desaturation study, as per ISO 80601-2-61. This is a highly objective measurement.
- For NIBP, ground truth is typically established by direct intra-arterial blood pressure measurements, not by expert consensus.
- For Respiratory Rate, the ground truth was "clinician-scored capnography device, manually scored end-tidal CO2 (EtCO2) capnography." This implies clinically trained personnel, but their specific qualifications or number are not provided.
- For Arrhythmia Analysis, and other subjective physiological monitoring parameters, the ground truth source is not explicitly mentioned but typically relies on expert interpretation of ECG waveforms or other data.
4. Adjudication Method for the Test Set
The document does not detail any adjudication methods (e.g., 2+1, 3+1) for the test set, as most of the parameters are quantitative measurements compared against an objective reference standard rather than subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This document describes a multi-parameter patient monitor, which is a measurement device, not an AI-assisted diagnostic imaging tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this type of device and was not conducted. The study aims to demonstrate that the device's measurements are accurate and equivalent to predicate devices, not to show an improvement in human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The entire device, including its algorithms for parameter measurement and arrhythmia detection, operates in a "standalone" fashion to generate the values and alarms displayed to the clinician. The performance validated (e.g., accuracy of SpO2, NIBP, RR, arrhythmia detection) is the inherent performance of the device's algorithms and hardware. While a human uses the device and interprets its output, the core measurements are algorithm-driven.
7. The Type of Ground Truth Used
- SpO2: CO-oximetry in a controlled desaturation study (objective, gold-standard reference for SpO2 saturation).
- NIBP: Direct intra-arterial blood pressure measurements (objective, gold-standard).
- Respiratory Rate: Clinician-scored capnography device, manually scored end-tidal CO2 (EtCO2) capnography. (This suggests an expert-derived observation from an objective measurement, or comparison to another well-established measurement device).
- ECG/Arrhythmia Detection and other parameters: The document implies comparison to established methods and compliance with relevant ISO standards, which would typically involve highly accurate reference measurements and possibly expert review of waveforms for specific event detection.
8. The Sample Size for the Training Set
The document does not provide information about a training set or its sample size. This is common for device clearances that focus on performance validation rather than machine learning algorithm development where distinct training and test sets are crucial. The device's algorithms are likely based on established physiological principles and signal processing, rather than deep learning from a massive training dataset.
9. How the Ground Truth for the Training Set was Established
As no specific training set is mentioned in the filing summary for this device, information regarding the establishment of its ground truth is not applicable or provided. The device's performance is demonstrated through its adherence to established international standards and clinical testing against reference methods.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
December 29, 2022
Shenzhen Comen Medical Instruments CO., LTD. Charlotte Lin Jingfang International Registration Engineer FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-District, Guangming District Shenzhen, Guangdong 51806 China
Re: K211619
Trade/Device Name: Multi-Parameter Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, DSI, MLD, DRT, DSJ, DXN, DSK, DPS, DXG, DSB, FLL, DQA, CCK, CBQ, CBS, CBR, CCL, NHQ, NHO, NHP, OLW, GXY Dated: December 2, 2022 Received: December 2, 2022
Dear Charlotte Lin Jingfang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shruti N. Mistry -S
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K211619
Device Name
Multi-parameter Patient Monitor, model: NC10, NC12
Indications for Use (Describe)
The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, alarming and storing of multiple physiological parameters These parameters include ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.
All parameters can be monitored on single adult, pediatric, and neonatal patients except:
- · BIS monitoring is intended for adult and pediatric patients only;
- · C.O. monitoring is restricted to adult patients only;
· Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population.
- · When using COMEM SpO2, the monitor is intended to be used on adult patients only.
- · NIBP measurement continual mode is not applicable to neonates.
The monitors are to be used in general healthes by clinical physicians or appropriate medical staff under the direction of physicians.
The monitors are not intended for helicopter transport, hospital ambulance, or home use.
The monitors do not measure, display, or trend changes in the ST segment.
The monitors do not intend for use as apnea monitors.
The monitors are not intended for use in MRI or CT environments.
The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.
| Type of Use (Select one or both, as applicable) |
|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
[X] Prescription Use (Part 21
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Section 5 - 510 (k) Summary
NC10 and NC12 Multi-parameter Patient Monitor
This 510(k) Summary is provided in accordance with the requirements of 21 CFR 807.92.
| Date: | 2nd December, 2022 | ||
|---|---|---|---|
| Submitter | SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD | ||
| Address | Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building | ||
| 2, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, | |||
| Shenzhen, 518106, Guangdong, China. | |||
| Contact | Chuanqing Zhu | ||
| Telephone | +86-18252006698 | ||
| Facsimile | +86-755-3431232 | ||
| Ee-mail | zhuchuanqing@szcomen.com | ||
| Devicetradename | NC10 and NC12 Multi-parameter Patient Monitor | ||
| Common name | Multi-parameter Patient Monitor | ||
| Classification Regulation, Classification name and Product Codes | |||
| Device Panel | RegulationClassificationnumber | Productcode | Description |
| Cardiovascular | §870.1025, II | MHX | Arrhythmia detector and alarm (includingST-segment measurement and alarm) |
| Cardiovascular | §870.1025, II | DSI | Arrhythmia detector and alarm (includingST-segment measurement and alarm). |
| Cardiovascular | §870.1025, II | MLD | Arrhythmia detector and alarm (includingST-segment measurement and alarm). |
| Cardiovascular | §870.2300, II | DRT | Monitor, Cardiac (IncludingCardiotachometer & Rate Alarm) |
| Cardiovascular | §870.1100, II | DSJ | Alarm, Blood-Pressure |
| Cardiovascular | §870.1130, II | DXN | System, Measurement, Blood-Pressure,Non-Invasive |
| Cardiovascular | §870.1110, II | DSK | Computer, Blood-Pressure |
| Cardiovascular | §870.2340, II | DPS | Electrocardiograph |
| Cardiovascular | §870.1435, II | DXG | Computer, Diagnostic, Pre-Programmed,Single-Function |
| Cardiovascular | §870.2770, II | DSB | Plethysmograph, Impedance |
| GeneralHospital | §880.2910, II | FLL | Thermometer, Electronic, Clinical |
| Anesthesiology | §870.2700, II | DQA | Oximeter |
| Anesthesiology | §868.1400, II | CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Anesthesiology | §868.1500, II | CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase(Anesthetic Concentration) |
| Anesthesiology | §868.1620, II | CBS | Analyzer, Gas, Halothane, Gaseous-Phase(Anesthetic Conc.) |
| Anesthesiology | §868.1700, II | CBR | Analyzer, Gas, Nitrous-Oxide, GaseousPhase (Anesthetic Conc.) |
| Anesthesiology | §868.1720, II | CCL | Analyzer, Gas, Oxygen, Gaseous-Phase |
| Anesthesiology | §868.1500, II | NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase(Anesthetic Concentration) |
| Anesthesiology | §868.1500, II | NHO | Analyzer, Gas, Desflurane, Gaseous-Phase(Anesthetic Concentration) |
| Anesthesiology | §868.1500, II | NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) |
| Neurology | §882.1400, II | OLW | Index-Generating ElectroencephalographSoftware |
| Neurology | §882.1320, II | GXY | Electrode, Cutaneous |
| PredicateDevice: | K191106, C50 and C80 Multi-parameter Patient Monitors, SHENZHEN COMENMEDICAL INSTRUMENTS CO., LTD | ||
| Devicedescription: | The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying,reviewing, alarming and storing multiple physiological parameters. These parametersinclude ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)),Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive bloodpressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide(CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.All parameters can be monitored on single adult, pediatric, and neonatal patients except:BIS monitoring is intended for adult patients only; C.O. monitoring is restricted to adult patients only; Arrhythmia analysis is intended for use with adult patients only and is not intendedand shall not be used on pediatric and neonatal population. When using COMEM SpO2, the monitor is intended to be used on adult patients only. NIBP measurement continual mode is not applicable to neonates. Both models are designed with:Same system framework and componentsSame hardware design principleSame software platformSame parameters measurement subsystems (including parameters modules and accessories)The only difference between NC10 and NC12 is the display size. | ||
| Indications forUse: | The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying,reviewing, alarming and storing of multiple physiological parameters. These parametersinclude ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), |
{4}------------------------------------------------
{5}------------------------------------------------
| Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive bloodpressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide(CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.All parameters can be monitored on single adult, pediatric, and neonatal patients except:• BIS monitoring is intended for adult and pediatric patients only;• C.O. monitoring is restricted to adult patients only;Arrhythmia analysis is intended to use on adult patients only and is not intended and shallnot be used on pediatric and neonatal population.• When using COMEM SpO2, the monitor is intended to be used on adult patients only.• NIBP measurement continual mode is not applicable to neonates. | |
|---|---|
| The monitors are to be used in general healthcare facilities by clinical physicians orappropriate medical staff under the direction of physicians.The monitors are not intended for helicopter transport, hospital ambulance, or home use.The monitors do not measure, display, or trend changes in the ST segment.The monitors do not intend for use as apnea monitors. | |
| The monitors are not intended for use in MRI or CT environments.The monitors are not used on patients who have a demonstrated need for cardiac monitoringknown arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes. | |
| TechnologicalComparison to | Both the subject devices and the predicate device provide a means for monitoring onepatient, collecting specific physiological data, processing the data for alarm conditions and |
| Predicate | display of numeric values and waveforms. |
| Devices: | In terms of indications for use, basic operation and performance specifications, the NC10 |
| and NC12 Multi-parameter Patient Monitor is equivalent to C50 and C80 multi-parameter | |
| Patient Monitors (K191106). All devices can provide monitoring such as ECG(3-lead , 5- | |
| lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate(RR), | |
| Temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive | |
| blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG) and | |
| Bispectral index (BIS)for a single patient. | |
| NC10 and NC12 restricted the arrhythmia analysis, BIS monitoring and COMEN SpO2 on | |
| adults only, which is a subset of C50 and C80 multi-parameter patient monitor. These do | |
| not affect the substantial equivalence of subject device and predicate device. | |
| Table below compares the key technological feature of the subject devices (NC10 and NC12 | |
| patient monitors) to the predicate device (K191106, C50 and C80 multi-parameter patient | |
| monitor). The features in gray are features that are different between the predicate devices | |
| and the subject devices. | |
| Device Comparison Table |
{6}------------------------------------------------
| Feature | Predicate device C50and C80 (K191106) | Subject devicesNC10 and NC12 | Comparison |
|---|---|---|---|
| MonitorSize | C80: 344mm×291 mm×165mmC50:291.7mm×250mm×146.5mm | NC12: 308mm× 257mm ×142mmNC10:265mm×227mm×141mm | Similar. Bothdevices met IEC60601-1. |
| Integrateddisplayscreen | color TFT LCDC80: 12.1 InchC50: 10.4 InchC80: 800×600 pixelsC50: 800×600 pixels | color TFT LCDNC12: 12.1 InchNC10: 10.4 InchNC12: Pixel: 800×600NC10: Pixel: 800×600 | SameSameSameSameSame |
| Powersupply | C50 and C80:Two rechargeableLithium-ion battery orAC power supply | NC10 and NC12:Two rechargeableLithium-ion battery orAC power supply | Same |
| Battery | 11.1V, 2200mAh or4400mAh | 11.1V, 2200mAh or4400mAh | Same |
| ECG | 3-lead, 5-lead and 12-lead selectable, heartrate (HR) | 3-lead, 5-lead and 12-lead selectable, heartrate (HR) | Same |
| ECG(ArrhythmiaAnalysis) | Asystole, ventricularfibrillation, R ON T,VT>2, Couplet, PVC,Bigeminy, Trigeminy,Brady (Bradycardia),PNC (Pacer NotCapture), PNP (PacerNot Pace), MissedBeats, Heart Pause,Irregular Heart Beat,VTAC (VentricularTachycardia), Tachy(Tachycardia), PVCsToo High, ExtremeTachycardia, ExtremeBradycardia,Ventricular Rhythm, | Asystole, ventricularfibrillation, R ON T,VT>2, Couplet, PVC,Bigeminy, Trigeminy,Brady (Bradycardia),PNC (Pacer NotCapture), PNP (PacerNot Pace), MissedBeats, Heart Pause,Irregular Heart Beat,VTAC (VentricularTachycardia), Tachy(Tachycardia), PVCsToo High, ExtremeTachycardia, ExtremeBradycardia,Ventricular Rhythm, | Same |
| Respiration | Method: Trans-thoracicimpedanceRange: | Method: Trans-thoracicimpedanceRange: | Same |
| adult:0-120 rpm; | adult:0-120 rpm; | ||
| pediatrics:0-150rpm; | pediatrics:0-150rpm; | ||
| neonate:0-150rpm | neonate:0-150rpm | ||
| Accuracy: | Accuracy: | ||
| 7 to 150rpm: ±2rpm or±2%, whichever isgreater. | 7 to 150rpm: ±2rpm or±2%, whichever isgreater. | ||
| 0 to 6rpm: not specified | 0 to 6rpm: not specified | ||
| Pulseoxygensaturation(SpO2) | Method: red andinfrared light method | Method: red andinfrared light method | Same |
| Masimo SpO2: | Masimo SpO2: | ||
| Range:1~100% | Range:1~100% | ||
| Accuracy: | Accuracy: | ||
| No motion Conditions: | No motion Conditions: | ||
| 70 to 100%: ±2%(inadult/pediatric mode) | 70 to 100%: ±2%(inadult/pediatric mode) | ||
| 70 to 100%: ±3% (inneonate mode) | 70 to 100%: ±3% (inneonate mode) | ||
| Motion conditions: | Motion conditions: | ||
| 70%~100%: ±3% | 70%~100%: ±3% | ||
| 1%~ 69%: Notspecified. | 1%~ 69%: Notspecified. | ||
| Nellcor SpO2: | Nellcor SpO2: | Same | |
| Range: 0~100% | Range: 0~100% | ||
| Accuracy:70 to 100%:±2% (adult/pediatric) | Accuracy:70 to 100%:±2% (adult/pediatric) | ||
| 70 to 100%: ±3%(neonate) | 70 to 100%: ±3%(neonate) | ||
| 0% to 69%: Notspecified. | 0% to 69%: Notspecified. | ||
| Comen SpO2: | Comen SpO2: | Different. | |
| Range: 0~100%; | Range: 0~100%; | The subjectdevices add | |
| Accuracy: 70 to 100%:±2% (adult/pediatricmode) | Accuracy: 70 to 100%:±3% (adult) | exceptions onneonate and | |
| 70 to 100%: ±3%(neonate mode) | 0% to 69%: Notspecified | pediatric use ofComen SpO2. | |
| 0% to 69%: Notspecified | The SpO2accuracy met ISO80601-2-61 andwas validated bythe clinical study. | ||
| Pulserate(PR) | PR FROM MasimoSpO2: | PR FROM MasimoSpO2: | Same |
| Range: 25~240bpm | Range: 25~240bpm | ||
| Accuracy: | Accuracy: | ||
| ±3bpm (withoutmotion) | ±3bpm (withoutmotion) | ||
| ±5bpm (with motion) | ±5bpm (with motion) | ||
| PR FROM NellcorSpO2: | PR FROM NellcorSpO2: | ||
| Range:20~300bpm | Range:20~300bpm | ||
| Accuracy: | Accuracy: | ||
| 20~250bpm: ±3bpm | 20~250bpm: ±3bpm | ||
| 251~300bpm: notspecified. | 251~300bpm: notspecified. | ||
| PR FROM COMENSpO2: | PR FROM COMENSpO2: | ||
| Range: 20bpm~254bpm; | Range: 20bpm~254bpm; | ||
| Accuracy: ±2bpm; | Accuracy: ±2bpm; | ||
| PR FROM IBP: | PR FROM IBP: | ||
| Range:25-350bpm | Range:25-350bpm | ||
| Accuracy:±1bpm or±1%, whichever isgreater | Accuracy:±1bpm or±1%, whichever isgreater | ||
| PR FROM NIBP : | PR FROM NIBP: | ||
| Range: 40 ~ 240 bpm; | Range: 40 ~ 240 bpm; | ||
| Accuracy: ±3bpm or ±3%, whichever is greater | Accuracy: ±3bpm or ±3%, whichever is greater | ||
| Non-invasivebloodpressure(NIBP) | Method: OscillometryRange:Adult:systolic:40-270 mmHgdiastolic:10-215 mmHgpediatrics:systolic:40-200 mmHgdiastolic:10-150 mmHgNeonate:systolic:40-140 mmHgdiastolic:10-100 mmHgError:Max mean error: ±5mmHg | Method: OscillometryRange:Adult:systolic: 40-270mmHgdiastolic: 10-215mmHgpediatrics:systolic:40-200mmHgdiastolic:10-150mmHgNeonate:systolic:40-135mmHgdiastolic:10-100mmHgError:Max mean error: ±5mmHg | Same |
| Max standard deviation: 8 mmHg | Max standard deviation: 8 mmHg | ||
| Temperature(Temp.) | Method: Thermal resistanceRange: 0-50°CAccuracy: ±0.1°C | Method: Thermal resistanceRange: 0-50°CAccuracy: ±0.1°C | Same |
| Carbondioxide(CO2) | Method: Infrared absorptionMasimo Sidestream/Mainstream CO2Module:Range: 0-190mmHg,0 | Method: Infrared absorptionMasimo Sidestream/Mainstream CO2Module:Range: 0-190mmHg,0 | Same |
| invasivebloodpressure(IBP) | Method: Direct invasive measurementRange: -50 to 300 mmHg | Method: Direct invasive measurementRange: -50 to 300 mmHg | Same |
| Accuracy: ±2% or ±1 mmHg, whichever is greater (excluding the sensor error) | Accuracy: ±2% or ±1 mmHg, whichever is greater (excluding the sensor error) | ||
| cardiacoutput(C.O.) | Method:Thermodilution methodRange: 0.1 to 20 L/minAccuracy: ±5% or ±0.1 L/min, whichever is greater | Method:Thermodilution methodRange: 0.1 to 20 L/minAccuracy: ±5% or ±0.1 L/min, whichever is greater | Same |
| anestheticgas (AG) | Method: Infrared absorptionRange:CO2: 0%~25%N2O: 0%~100%Hal: 0%~25%Enf: 0%~25%Iso: 0%~25%Sev: 0%~25%Des: 0%~25%O2: 0% | Method: Infrared absorptionRange:CO2: 0%~25%N2O: 0%~100%Hal: 0%~25%Enf: 0%~25%Iso: 0%~25%Sev: 0%~25%Des: 0%~25%O2: 0% | Same |
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
| BIS | Range and accuracy: | Range and Accuracy: | Same | |
|---|---|---|---|---|
| SQI: 0-100%; accuracy:1%. | BIS: 0-100; accuracy:1%. | |||
| EMG: 0~100dB;accuracy: 1%. | SQI: 0-100%; accuracy:1%. | |||
| BIS: 0-100; accuracy:1%. | EMG: 0~100dB;accuracy: 1%. | |||
| SR: 0~100%; accuracy:1%. | ESR: 0~100%;accuracy: 1%. | |||
| Substantial Equivalence Conclusion: | ||||
| The above-detailed technical specification comparison for each parameter between thesubject device and the predicate devices (C50 and C80 multi-parameter patient monitor)shows the difference lies in monitor size and Comen SpO2. Therefore, we declared thatthe NC10 and NC12 Multi-parameter Patient Monitors can be found substantiallyequivalent to the predicate device. | ||||
| PerformanceData | The following performance data are provided to support the substantial equivalencedetermination. | |||
| Software Verification and Validation Testing | ||||
| Software verification and validation testing were conducted, and documentation wasprovided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance forthe Content of Premarket Submissions for Software Contained in Medical Devices." | ||||
| Biocompatibility Testing | ||||
| The accessories with patient contact have been evaluated by biocompatibility testing inaccordance with ISO 10993-1. | ||||
| Bench test | ||||
| The NC10 and NC12 Multi-parameter Patient Monitor have been tested and found to be incompliance with the following safety, performance and electromagnetic compatibilitystandards: | ||||
| ● | ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012Medical Electrical Equipment -Part 1: General Requirements For Basic Safety And Essential Performance (IEC60601-1:2005, MOD) | |||
| ● | IEC 60601-1-2 Edition 4.0: 2014-02 Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And Essential Performance - Collateral Standard:Electromagnetic Compatibility - Requirements And Tests | |||
| ● | IEC 60601-1-8 Edition 2.1 2012-11Medical Electrical Equipment - Part 1-8: GeneralRequirements For Basic Safety And Essential Performance - Collateral Standard:General Requirements, Tests And Guidance For Alarm Systems In Medical ElectricalEquipment And Medical Electrical Systems | |||
| ● | IEC 60601-2-27 Edition 3.0 2011-03 Medical Electrical Equipment - Part 2-27:Particular Requirements For The Basic Safety And Essential Performance OfElectrocardiographic Monitoring Equipment [Including: Corrigendum 1 (2012)] |
{12}------------------------------------------------
| • | IEC 80601-2-30: Edition 2.0 2018-03 Medical electrical equipment - Part 2-30:Particular requirements for the basic safety and essential performance of automatednon-invasive sphygmomanometers |
|---|---|
| • | IEC 60601-2-34 Edition 3.0 2011-05 Medical Electrical Equipment - Part 2-34:Particular Requirements For The Basic Safety, Including Essential Performance, OfInvasive Blood Pressure Monitoring Equipment |
| • | ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56:Particular requirements for basic safety and essential performance of clinicalthermometers for body temperature measurement. [Including: Amendment 1 (2018)]. |
| • | ISO 80601-2-61 Second Edition 2017-12 Medical Electrical Equipment - Part 2-61:Particular Requirements For Basic Safety And Essential Performance Of PulseOximeter Equipment |
| • | ISO 80601-2-55 Second Edition 2018-02 Medical Electrical Equipment - Part 2-55:Particular Requirements For The Basic Safety And Essential Performance OfRespiratory Gas Monitors |
| • | ANSI AAMI EC57:2012 Testing And Reporting Performance Results Of CardiacRhythm And ST-Segment Measurement Algorithms |
| • | IEC 80601-2-49:2018 Medical electrical equipment - Part 2-49: Particularrequirements for the basic safety and essential performance of multifunction patientmonitoring equipment. |
| • | IEC 80601-2-26:2019 Medical electrical equipment - Part 2-26: Particularrequirements for the basic safety and essential performance of electroencephalographs. |
| • | EN 1060-1:1995+A2:2009 Non-invasive sphygmomanometers - Part 1: Requirementsand test methods for non-automated measurement type |
| • | EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3:Supplementary requirements for electro-mechanical blood pressure measuringsystems |
| • | IEC 60601-1-6 Edition 3.1 2013-10 Medical Electrical Equipment - Part 1-6: GeneralRequirements For Basic Safety And Essential Performance - Collateral Standard:Usability |
| • | IEC 62366-1 Edition 1.0 2015-02 Medical Devices - Part 1: Application Of UsabilityEngineering To Medical Devices [Including CORRIGENDUM 1 (2016)] |
| • | ISO 14971 Third Edition 2019-12 Medical devices - Application of riskmanagement to medical devices |
| Clinical studies | |
| The clinical accuracy of non-invasive blood pressure (NIBP) determination, SpO2measurement, and respiratory rate were validated for the intended patient population.Clinical data is provided to support the determination of substantial equivalence withpredicated devices that are currently marketed for the same intended use. | |
| • | The accuracy of the SpO2 accuracy during non-motion conditions as compared to CO-oximetry in a controlled desaturation study was validated using the method outlined in |
| ISO 80601-2-61:2017 and the FDA guidance Pulse Oximeters - Premarket NotificationSubmissions [510(k)s]: Guidance for Industry and Food and Drug AdministrationStaff, March 2013. | |
| • The clinical accuracy of non-invasive blood pressure determination was validatedaccording to ISO 81060-2 which contains the requirements for clinical accuracy andthe protocols for investigating the NIBP determination clinical accuracy. | |
| • The clinical accuracy of respiratory rate was validated by clinical testing to comparethe measurement of the subject device and that of a clinician-scored capnographydevice, manually scored end-tidal CO2 (EtCO2) capnography. | |
| All clinical accuracy validation studies were conducted in accordance with standard ISO14155:2020. | |
| SummaryBased on the non-clinical and clinical performance above, we demonstrate that the NC10and NC12 multi-parameter patient monitors were substantially equivalent and perform aswell as the predicate device. | |
| Conclusion: | The NC10 and NC12 Multi-Parameter Patient Monitor are substantially equivalent to thepredicate devices (C50 and C80 multi-parameter patient monitor, K191106) in terms ofindication for use and technological characteristics. Performance testing and compliancewith FDA-recognized consensus standards demonstrate that NC10/NC12 aresubstantially equivalent to the predicate device. |
{13}------------------------------------------------
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.